Regulatory Education for Industry (REdI) Annual Conference 2023 June 5 - 9, 2023

Virtual | Virtual

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• Date: June 5 - 9, 2023
• Time: 8:40 AM - 4:30 PM ET

Topics & Presentations Day 1	Speakers
REdI Annual Conference 2023 – Day 1 – FDA Welcome and Keynote
FDA Welcome and Keynote Speaker	Robert M. Califf, MD Commissioner of Food and Drugs Food and Drug Administration
Plenary: User Fee Impact on FDA Programs.pdf	Jeff Shuren, MD, JD Director Center for Devices and Radiological Health (CDRH) Patrizia Cavazzoni, MD Director Center for Drug Evaluation and Research (CDER) Peter Marks, MD, PhD Director Center for Biologics Evaluation and Research (CBER)
REdI Annual Conference 2023 – Day 1 – Session 2
Biosimilar Program Updates and What’s New Under BsUFA III.pdf	Stacey Ricci, M.Eng, ScD, Director of Scientific Review Staff (SRS) Office of Therapeutic Biologics and Biosimilars (OTBB) Office of New Drugs (OND) | CDER Kimberly Maxfield, PhD BsUFA Regulatory Science Program Coordinator OTBB | OND | CDER
FDA Formal Meetings: What's New Under PDUFA, BsUFA, and OMUFA.pdf	Elizabeth Thompson, MS Chief Project Management Staff Division of Regulatory Operations for Nonprescription Drugs (DRO-NPD) Office of Regulatory Operations (ORO) OND | CDER
Question and Answer Panel	Stacey Ricci, Kimberly Maxfield, and Elizabeth Thompson
REdI Annual Conference 2023 – Day 1 – Session 3
ESG (Electronic Submissions Gateway)…The Road to Modernization.pdf	Jessica Bernhardt, MS AdminApps Program Manager, ESG Program Manager Office of Information Management & Technology (OIMT) Office of Digital Transformation (ODT) Office of the Commissioner (OC)
eCTD v4.0 and Latest on eCTD.pdf	Jonathan Resnick Project Management Officer Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI) Office of Strategic Programs (OSP) | CDER
Electronic Submission Practicalities and Application Tips.pdf	Heather Crandall Operations Research Analyst DDMSS | OBI | OSP | CDER
Question and Answer Panel	Jessica Bernhardt, Jonathan Resnick, and Heather Crandall
REdI Annual Conference 2023 – Day 1 – Session 4
Data Standards.pdf	Hao (Ray) Wang Director Data Standards Staff (DSS) Office of Strategic Program (OSP) | CDER
PDUFA VI Goals for Digital Health Technologies - A Regulatory Review Perspective.pdf	Andrew Potter Mathematical Statistician Division of Biometrics I (DBI) Office of Biostatistics (OB) Office of Translational Sciences (OTS) | CDER
PDUFA VII Goals for Digital Health Technologies (DHT) - An IT Perspective.pdf	Mary Ann Slack Director OSP | CDER
Question and Answer Panel	Hao (Ray) Wang, Andrew Potter, and Mary Ann Slack

 

Topics & Presentations Day 2	Speakers
REdI Annual Conference 2023 – Day 2 – Session 1
Leveraging SBIA's Resources.pdf	Renu Lal, PharmD, BCACP Lieutenant Commander United States Public Health Service (USPHS) Team Lead, Division of Drug Information (DDI) Deputy Director, SBIA OCOMM | CDER
Overview of FDA Split Real Time Application Review (STAR) Pilot Program.pdf	LaShawn Schnupp, PharmD Senior Regulatory Health Project Manager STAR Program Manager Program Development, Implementation, and Management Staff (PDIMS) Office of Program Operations (OPO) | OND | CDER J. Paul Phillips, MS Director OPO | OND | CDER
Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review.pdf	Lolita Sterrett, PharmD Associate Director for Human Factors Division of Medication Error Prevention and Analysis 2 (DMEPA 2) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) CDER
Question and Answer Panel	LaShawn Schnupp, J. Paul Phillips, and Lolita Sterrett
REdI Annual Conference 2023 – Day 2 – Session 2
The Modernization of Clinical Trials through Digital Health Technologies (DHT), Decentralized Clinical Trials (DCT) and Point of Care Trials.pdf	Beth Kunkoski Health Science Policy Analyst Clinical Methodologies Office of Medical Policy (OMP) | CDER
PDUFA VII Real-World Evidence.pdf	Kimberly Smith CAPT, USPHS Real-World Evidence (RWE) Analytics OMP | CDER
Question and Answer Panel	Beth Kunkoski and Kimberly Smith
REdI Annual Conference 2023 – Day 2 – Session 3
PDUFA VII PMR (Postmarketing Requirements) Commitments: Preapproval & Postapproval.pdf	Kathleen (Kathy) Weil Senior Science Policy Analyst PMR/PMC Program Manager Safety Policy Research and Initiatives Team (SPiRIT) Immediate Office | OND | CDER
How CDER is Accelerating Rare Disease Cures and the PDUFA VII Rare Disease Endpoint Advancement Pilot Program.pdf	Kerry Jo Lee, MD Associate Director for Rare Diseases Rare Diseases Team Division of Rare Diseases and Medical Genetics (DRDMG) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM) OND | CDER
PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates.pdf	Paresma Patel, PhD Director, Division of New Drug API (DNDAPI) Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) | CDER
Question and Answer Panel	Kathleen (Kathy) Weil, Kerry Jo Lee and Paresma Patel
REdI Annual Conference 2023 – Day 2 – Session 4 and Closing
Best Practices for Human Drug Product Recalls.pdf	Doris Chin Consumer Safety Officer Incidents, Recalls and Shortages Branch Division of Supply Chain Integrity Office of Drug Security, Integrity, and Response (OSDIR) Office of Compliance (OC) | CDER
A Rough Guide to Biologics Manufacturing.pdf	Joel Welch, PhD Associate Director for Science & Biosimilar Strategy Chair for Emerging Technology Team Office of Biotechnology Products (OBP) OPQ | CDER Chris Downey, PhD Director, Division of Biotech Manufacturing Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
Question and Answer Panel	Doris Chin, Joel Welch, and Chris Downey
Day Two Closing	Brenda Stodart, PharmD, BCGP, RAC-US Captain, United States Public Health Service Director, Small Business, and Industry Assistance (SBIA) Division of Drug Information (DDI) | Office of Communications (OCOMM) | CDER

Visit CDER Small Business and Industry Assistance Page

June 7 Recording: Devices Track

June 8 Recording: Devices and Biologics Track

June 9 Recording: Biologics Track

Device Track Slides

Biologics Track Slides

Drugs, Devices, and Biologics

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

 

KEYNOTE SPEAKER
Robert M. Califf M.D., MACC
Commissioner of Food and Drugs

 

Patrizia Cavazzoni M.D.
Director
Center for Drug Evaluation and Research (CDER)

Jeff Shuren M.D., J.D.
Director
Center for Devices and Radiological Health (CDRH)

Peter Marks M.D., PhD.
Director
Center for Biologics Evaluation and Research (CBER)

 

NO COST Conference

Agenda

PLENARY

Federal law authorizes the FDA to collect user fees which help the FDA fulfill its mission of promoting and protecting the public health. Most major user fee programs run in five-year cycles, and the past year saw the launch of the current cycle for CDER, CBER, and CDRH. This session will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.

DRUGS TRACK

The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.

Topics Include

• New Meeting Types, including What's New Under PDUFA, BsUFA, and OMUFA
• PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates
• Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review

Intended Audience

• Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
• Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
• Industry professionals at all levels of expertise

DEVICES TRACK

The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

Topics Include

• Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483
• Premarket Notification [510(k)] Program; Quality System Principles
• Tips and Best Practices for High Quality Regulatory Submissions
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Intended Audience

• A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
• A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
• An establishment seeking to understand their regulatory responsibilities for handling complaints about their medical devices.

BIOLOGICS TRACK

The biologics track will focus on the developmental and regulatory topics relevant to advanced therapies, including cellular and gene therapies, tissue-engineered and other biological products. The speakers will present updates on programmatic enhancements mandated by PDUFA-VII, including new regulatory programs, stakeholder communications and much more.

Topics Include

• IND readiness: contents of preclinical and clinical parts; Expanded Access INDs
• Product development challenges and Chemistry, Manufacturing, and Controls (CMC) Developmental Readiness Pilot program
• Estimand and Complex Innovative Design (CID) Program in application to CBER biologics

Intended Audience

• Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
• Regulatory affairs and other professionals working with submissions of INDs and BLAs to the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research
• Industry and consulting professionals working with advanced therapies, cell- or tissue-based products, and devices used with biological products

FDA RESOURCES

Plenary

• Milestones in U.S. Food and Drug Law
• FDA User Fee Programs
• FDA: User Fees Explained

Drugs

• CDER SBIA Learn: Webinars, Conferences, Trainings
• Search for Regulatory References | Drugs
• CDER Offices and Divisions | FDA

Devices

• Medical Device User Fees
• CDRH Learn
• FDA’s Division of Industry and Consumer Education (DICE)

Biologics

• Interactions with Office of Therapeutic Products (formerly Office of Tissues and Advanced Therapies
• OTP Learn
• Biologics Procedures (SOPPs)